LONDON – Middle-aged adults who watch TV for an average of 5 or more hours per night face an adjusted 6.5-fold increased risk of fatal pulmonary embolism, compared with those who watch less than 2.5 hours per night, Toru Shirakawa reported at the annual congress of the European Society of Cardiology.

This was the key lesson gleaned from an analysis from the Japan Collaborative Cohort Study, the first large-scale prospective investigation of the relationship between prolonged television watching and pulmonary embolism (PE). The study included 86,024 Japanese participants aged 40-79 years prospectively followed for a median of 18.4 years, explained Mr. Shirakawa, a medical student at Osaka (Japan) University.

And while many busy medical professionals might presume 5 hours–plus of TV watching per night constitutes extreme behavior, that’s hardly the case. Indeed, according to the Nielsen survey, American adults watch an average of 4.85 hours of TV nightly.

During the study period there were 59 confirmed deaths from PE. In a multivariate analysis adjusted for sex and baseline age, cardiovascular risk factors, and physical activity level, a strong dose-response relationship was evident between hours of TV viewing and fatal PE.

This association was most pronounced in the 40- to 59-year-olds. Using as a reference group subjects who watched less than 2.5 hours per day, those who watched 2.5-4.9 hours had an adjusted 3.14-fold increased risk of fatal PE. Individuals who watched 5 hours or more – less than the average length of two American football games – were at 6.49-fold increased risk.

The same dose-response association was evident in the full study population spanning ages 40 through 79 years at entry. However, the magnitude of risk attributable to prolonged television watching in the overall group wasn’t as great, since 60- to 79-year-olds face multiple age-related competing mortality risks. Still, 40- to 79-year-olds who watched at least 5 hours of TV daily had an adjusted 2.36-fold greater risk of fatal PE, compared with those who watched for less than 2.5 hours.

Mr. Shirakawa observed that the mechanism of injury is presumably the same as previously reported in studies of “shelter death” during the bombing of London during World War II, as well as “economy-class syndrome,” first described in conjunction with long-distance airplane flights in 1954. Basically, prolonged leg immobility leads to inadequate circulation and resultant venous clot formation. But prolonged TV watching is a much more common risk factor than is economy-class syndrome, he noted.

“The take-home message is this: Public awareness of the risk of pulmonary embolism from lengthy leg immobility is essential. To prevent the occurrence of pulmonary embolism, we recommend the same preventive behavior used against economy-class syndrome. That is, take a break, stand up, and walk around during the television viewing. And drink water to prevent dehydration; that is also important,” Mr. Shirakawa said.

Session cochair Dr. José Ramón González Juanatey observed that the true burden of PE triggered by prolonged TV watching is far greater than documented in the Japanese study because the analysis focused exclusively on fatal cases.

“Only about 10% of cases of pulmonary embolism are immediately fatal events,” commented Dr. González Juanatey of the University of Santiago de Compostela and president of the Spanish Society of Cardiology.

“The absolute risk may be fairly small, but it’s a devastating thing to have happen to you,” added cochair Dr. Ian Graham, professor of cardiovascular medicine at Trinity College, Dublin.

The Japan Collaborative Cohort Study has been funded by scientific grants from various Japanese health and education ministries. Mr. Shirakawa reported having no financial conflicts.

[email protected]

LONDON – Middle-aged adults who watch TV for an average of 5 or more hours per night face an adjusted 6.5-fold increased risk of fatal pulmonary embolism, compared with those who watch less than 2.5 hours per night, Toru Shirakawa reported at the annual congress of the European Society of Cardiology.

This was the key lesson gleaned from an analysis from the Japan Collaborative Cohort Study, the first large-scale prospective investigation of the relationship between prolonged television watching and pulmonary embolism (PE). The study included 86,024 Japanese participants aged 40-79 years prospectively followed for a median of 18.4 years, explained Mr. Shirakawa, a medical student at Osaka (Japan) University.

And while many busy medical professionals might presume 5 hours–plus of TV watching per night constitutes extreme behavior, that’s hardly the case. Indeed, according to the Nielsen survey, American adults watch an average of 4.85 hours of TV nightly.

During the study period there were 59 confirmed deaths from PE. In a multivariate analysis adjusted for sex and baseline age, cardiovascular risk factors, and physical activity level, a strong dose-response relationship was evident between hours of TV viewing and fatal PE.

This association was most pronounced in the 40- to 59-year-olds. Using as a reference group subjects who watched less than 2.5 hours per day, those who watched 2.5-4.9 hours had an adjusted 3.14-fold increased risk of fatal PE. Individuals who watched 5 hours or more – less than the average length of two American football games – were at 6.49-fold increased risk.

The same dose-response association was evident in the full study population spanning ages 40 through 79 years at entry. However, the magnitude of risk attributable to prolonged television watching in the overall group wasn’t as great, since 60- to 79-year-olds face multiple age-related competing mortality risks. Still, 40- to 79-year-olds who watched at least 5 hours of TV daily had an adjusted 2.36-fold greater risk of fatal PE, compared with those who watched for less than 2.5 hours.

Mr. Shirakawa observed that the mechanism of injury is presumably the same as previously reported in studies of “shelter death” during the bombing of London during World War II, as well as “economy-class syndrome,” first described in conjunction with long-distance airplane flights in 1954. Basically, prolonged leg immobility leads to inadequate circulation and resultant venous clot formation. But prolonged TV watching is a much more common risk factor than is economy-class syndrome, he noted.

“The take-home message is this: Public awareness of the risk of pulmonary embolism from lengthy leg immobility is essential. To prevent the occurrence of pulmonary embolism, we recommend the same preventive behavior used against economy-class syndrome. That is, take a break, stand up, and walk around during the television viewing. And drink water to prevent dehydration; that is also important,” Mr. Shirakawa said.

Session cochair Dr. José Ramón González Juanatey observed that the true burden of PE triggered by prolonged TV watching is far greater than documented in the Japanese study because the analysis focused exclusively on fatal cases.

“Only about 10% of cases of pulmonary embolism are immediately fatal events,” commented Dr. González Juanatey of the University of Santiago de Compostela and president of the Spanish Society of Cardiology.

“The absolute risk may be fairly small, but it’s a devastating thing to have happen to you,” added cochair Dr. Ian Graham, professor of cardiovascular medicine at Trinity College, Dublin.

The Japan Collaborative Cohort Study has been funded by scientific grants from various Japanese health and education ministries. Mr. Shirakawa reported having no financial conflicts.

[email protected]

LONDON – Middle-aged adults who watch TV for an average of 5 or more hours per night face an adjusted 6.5-fold increased risk of fatal pulmonary embolism, compared with those who watch less than 2.5 hours per night, Toru Shirakawa reported at the annual congress of the European Society of Cardiology.

This was the key lesson gleaned from an analysis from the Japan Collaborative Cohort Study, the first large-scale prospective investigation of the relationship between prolonged television watching and pulmonary embolism (PE). The study included 86,024 Japanese participants aged 40-79 years prospectively followed for a median of 18.4 years, explained Mr. Shirakawa, a medical student at Osaka (Japan) University.

And while many busy medical professionals might presume 5 hours–plus of TV watching per night constitutes extreme behavior, that’s hardly the case. Indeed, according to the Nielsen survey, American adults watch an average of 4.85 hours of TV nightly.

During the study period there were 59 confirmed deaths from PE. In a multivariate analysis adjusted for sex and baseline age, cardiovascular risk factors, and physical activity level, a strong dose-response relationship was evident between hours of TV viewing and fatal PE.

This association was most pronounced in the 40- to 59-year-olds. Using as a reference group subjects who watched less than 2.5 hours per day, those who watched 2.5-4.9 hours had an adjusted 3.14-fold increased risk of fatal PE. Individuals who watched 5 hours or more – less than the average length of two American football games – were at 6.49-fold increased risk.

The same dose-response association was evident in the full study population spanning ages 40 through 79 years at entry. However, the magnitude of risk attributable to prolonged television watching in the overall group wasn’t as great, since 60- to 79-year-olds face multiple age-related competing mortality risks. Still, 40- to 79-year-olds who watched at least 5 hours of TV daily had an adjusted 2.36-fold greater risk of fatal PE, compared with those who watched for less than 2.5 hours.

Mr. Shirakawa observed that the mechanism of injury is presumably the same as previously reported in studies of “shelter death” during the bombing of London during World War II, as well as “economy-class syndrome,” first described in conjunction with long-distance airplane flights in 1954. Basically, prolonged leg immobility leads to inadequate circulation and resultant venous clot formation. But prolonged TV watching is a much more common risk factor than is economy-class syndrome, he noted.

“The take-home message is this: Public awareness of the risk of pulmonary embolism from lengthy leg immobility is essential. To prevent the occurrence of pulmonary embolism, we recommend the same preventive behavior used against economy-class syndrome. That is, take a break, stand up, and walk around during the television viewing. And drink water to prevent dehydration; that is also important,” Mr. Shirakawa said.

Session cochair Dr. José Ramón González Juanatey observed that the true burden of PE triggered by prolonged TV watching is far greater than documented in the Japanese study because the analysis focused exclusively on fatal cases.

“Only about 10% of cases of pulmonary embolism are immediately fatal events,” commented Dr. González Juanatey of the University of Santiago de Compostela and president of the Spanish Society of Cardiology.

“The absolute risk may be fairly small, but it’s a devastating thing to have happen to you,” added cochair Dr. Ian Graham, professor of cardiovascular medicine at Trinity College, Dublin.

The Japan Collaborative Cohort Study has been funded by scientific grants from various Japanese health and education ministries. Mr. Shirakawa reported having no financial conflicts.

[email protected]

LONDON – The factor Xa inhibitor rivaroxaban was associated with low rates of bleeding and stroke in two observational studies that included more than 45,000 people with nonvalvular atrial fibrillation.

The XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) study involved 6,784 individuals treated at centers in Europe, Canada, and Israel. The incidence of major bleeding was 2.1% per year and the risk of stroke was 0.7% per year. Rates of fatal, critical organ, and intracranial bleeding were also low at 0.2%, 0.7%, and 0.4% per year, respectively.

Sara Freeman/Frontline Medical News

“The rates of stroke and systemic embolism, all strokes and gastrointestinal bleeding were markedly lower in XANTUS in comparison to ROCKET-AF,” noted Dr. John Camm who presented the XANTUS study findings at the annual congress of the European Society of Cardiology. “Major bleeding was also largely reduced in XANTUS, however the death rate and intracranial hemorrhage rate was similar,” he added.

Dr. Camm, who is professor of clinical cardiology at St George’s Hospital in London, noted that the patient populations and the design of the XANTUS study and phase III ROCKET-AF trial (N Engl J Med. 2011;365:883-91) were slightly different. Patients in the single-arm, prospective, observational XANTUS study were recruited from routine primary care practices and had an overall lower risk of stroke than those enrolled in the randomized, double-blind, controlled clinical trial who were at more moderate to high risk respective CHADS₂ scores of 2.0 and 3.5. The incidence of major bleeding was also slightly higher in the ROCKET-AF, at 3.6% per year, which was similar to that seen with warfarin (3.4%; P = .58), the active comparator used.

Nevertheless, the findings of the XANTUS study, which were published online simultaneously with their presentation at the conference (Eur Heart J. Sep 1. doi: 10.1093/eurheartj/ehv466), highlight the “real-world” safety of rivaroxaban, Dr. Camm said.

Results from the separate PMSS (Post-Marketing Safety Surveillance) study reported in a poster at the meeting were similar. The PMSS study is being conducted in the United States and is an ongoing, retrospective, 5-year, observational study of more than 39,000 patients with nonvalvular atrial fibrillation. At 2 years follow-up, the incidence of major bleeding was 2.89% per year and the incidence of fatal bleeding was 0.1% per year (Eur Heart J. 2015;36:687.P4066).

“Real-world research is an essential complement to clinical trials and helps inform treatment decisions,” PMSS study investigator Dr. Frank Peacock said in a press release issued by Janssen. Dr. Peacock, who is professor of emergency medicine at Baylor College of Medicine in Houston, added, “These studies confirm the safety profile of rivaroxaban in real-world settings around the globe.”

The XANTUS and PMSS studies are part of a large postlicensing program and were respectively designed to meet European Medicines Agency and U.S. Food and Drug Administration requirements on the long-term monitoring of medicines. There are also similar programs running in other world regions, such as XANTUS-EL and XANAP.

Other real-world data gleaned from electronic medical records (EMRs) comparing the potential bleeding risks of the factor Xa inhibitor apixaban (Eliquis) versus other available non–vitamin K antagonists (NOACs) including rivaroxaban and the direct thrombin inhibitor dabigatran (Pradaxa) were reported in several posters supported by Bristol-Myers Squibb and Pfizer and in an oral presentation given by Dr. Gregory Lip of the University of Birmingham, England.

Two of the posters reported data from retrospective analyses of different United States EMRs of 29,338 and 35, 757 patients, respectively, with nonvalvular atrial fibrillation newly started on a NOAC or warfarin in 2013 or 2014. Most were started on warfarin (43.3%/69.6%), followed by rivaroxaban (34.3%/17.9%), dabigatran (14.2%/6.8%), and apixaban (8.2%/5.7%).

Results of the first study (Eur Heart J. 2015;36:1085.P6217) showed that patients newly starting treatment with a NOAC had significantly lower rates of major bleeding than those starting treatment with warfarin, which was 4.6% per year versus 2.35% per year for apixiban, 3.38% per year for dabigatran, and 4.57% per year for rivaroxaban in the first study.

In the second study (Eur Heart J. 2015;36:1085.P6215) the respective adjusted hazard ratios for bleeding risk were 1.094, 0.747 and 0.679, comparing rivaroxaban, apixaban, and dabigatran against warfarin.

Other data gleaned from separate U.S. EMRs suggested that apixaban was associated with fewer bleeding-related hospital readmissions than either rivaroxaban or dabigatran in hospitalized patients with nonvalvular atrial fibrillation (Eur Heart J. 2015;36: 1085.P6211).

Dr. Lip presented 6-month follow-up data on more than 60,000 patients with nonvalvular atrial fibrillation who were treated with one of the three NOACs that was recorded in a U.S. medical claims database (Eur Heart J. 2015;36:339.1975). Most of the patients were treated with rivaroxaban (50.6%), with 34.8% treated with dabigatran and 14.6% with apixaban. Unadjusted data showed that the rates of major bleeding were 20.2% per year, 13.2% per year, and 14.5% per year, respectively.

Dr. Lip observed that, after adjusting the data, patients taking dabigatran had higher rates of clinically relevant nonmajor gastrointestinal bleeding (HR =1.24), and that those taking rivaroxaban were more likely to have major (HR = 3.6), clinically relevant nonmajor (HR = 1.43), or any bleeding (HR = 1.41) when compared with apixaban users.

“Larger cohort studies and longer follow-up data of general nonvalvular atrial fibrillation populations will be needed to confirm these early observations,” Dr. Lip concluded.

While real-world research of course has its limitations and cannot replace clinical trial findings as a means to accurately compare the clinical efficacy or safety profiles of different medicines, such studies do provide information that can help inform clinical practice.

“With 10 million people in Europe alone affected by atrial fibrillation, a number that is only expected to increase, real-world insights on routine anticoagulation management in everyday clinical practice is increasingly important for physicians and patients,” Dr. Camm noted in a media release on the XANTUS trial issued by the European Society of Cardiology.

Dr. Camm added: “These real-world insights from XANTAS complement and expand on what we already know from clinical trials, and provide physicians with reassurance to prescribe rivaroxaban as an effective and well-tolerated treatment option for the broad range of patients with atrial fibrillation seen in their everyday practice.”

The XANTUS and PMSS studies were supported by Bayer HealthCare and Janssen. The other studies mentioned were supported by Bristol-Myers Squibb and Pfizer. Dr. Camm disclosed acting as a consultant for Bayer Healthcare and other health care companies. Dr. Lip disclosed acting as a consultant for Bayer Healthcare, Bristol-Myers Squibb, and Pfizer as well as other health care companies.

LONDON – The factor Xa inhibitor rivaroxaban was associated with low rates of bleeding and stroke in two observational studies that included more than 45,000 people with nonvalvular atrial fibrillation.

The XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) study involved 6,784 individuals treated at centers in Europe, Canada, and Israel. The incidence of major bleeding was 2.1% per year and the risk of stroke was 0.7% per year. Rates of fatal, critical organ, and intracranial bleeding were also low at 0.2%, 0.7%, and 0.4% per year, respectively.

Sara Freeman/Frontline Medical News

“The rates of stroke and systemic embolism, all strokes and gastrointestinal bleeding were markedly lower in XANTUS in comparison to ROCKET-AF,” noted Dr. John Camm who presented the XANTUS study findings at the annual congress of the European Society of Cardiology. “Major bleeding was also largely reduced in XANTUS, however the death rate and intracranial hemorrhage rate was similar,” he added.

Dr. Camm, who is professor of clinical cardiology at St George’s Hospital in London, noted that the patient populations and the design of the XANTUS study and phase III ROCKET-AF trial (N Engl J Med. 2011;365:883-91) were slightly different. Patients in the single-arm, prospective, observational XANTUS study were recruited from routine primary care practices and had an overall lower risk of stroke than those enrolled in the randomized, double-blind, controlled clinical trial who were at more moderate to high risk respective CHADS₂ scores of 2.0 and 3.5. The incidence of major bleeding was also slightly higher in the ROCKET-AF, at 3.6% per year, which was similar to that seen with warfarin (3.4%; P = .58), the active comparator used.

Nevertheless, the findings of the XANTUS study, which were published online simultaneously with their presentation at the conference (Eur Heart J. Sep 1. doi: 10.1093/eurheartj/ehv466), highlight the “real-world” safety of rivaroxaban, Dr. Camm said.

Results from the separate PMSS (Post-Marketing Safety Surveillance) study reported in a poster at the meeting were similar. The PMSS study is being conducted in the United States and is an ongoing, retrospective, 5-year, observational study of more than 39,000 patients with nonvalvular atrial fibrillation. At 2 years follow-up, the incidence of major bleeding was 2.89% per year and the incidence of fatal bleeding was 0.1% per year (Eur Heart J. 2015;36:687.P4066).

“Real-world research is an essential complement to clinical trials and helps inform treatment decisions,” PMSS study investigator Dr. Frank Peacock said in a press release issued by Janssen. Dr. Peacock, who is professor of emergency medicine at Baylor College of Medicine in Houston, added, “These studies confirm the safety profile of rivaroxaban in real-world settings around the globe.”

The XANTUS and PMSS studies are part of a large postlicensing program and were respectively designed to meet European Medicines Agency and U.S. Food and Drug Administration requirements on the long-term monitoring of medicines. There are also similar programs running in other world regions, such as XANTUS-EL and XANAP.

Other real-world data gleaned from electronic medical records (EMRs) comparing the potential bleeding risks of the factor Xa inhibitor apixaban (Eliquis) versus other available non–vitamin K antagonists (NOACs) including rivaroxaban and the direct thrombin inhibitor dabigatran (Pradaxa) were reported in several posters supported by Bristol-Myers Squibb and Pfizer and in an oral presentation given by Dr. Gregory Lip of the University of Birmingham, England.

Two of the posters reported data from retrospective analyses of different United States EMRs of 29,338 and 35, 757 patients, respectively, with nonvalvular atrial fibrillation newly started on a NOAC or warfarin in 2013 or 2014. Most were started on warfarin (43.3%/69.6%), followed by rivaroxaban (34.3%/17.9%), dabigatran (14.2%/6.8%), and apixaban (8.2%/5.7%).

Results of the first study (Eur Heart J. 2015;36:1085.P6217) showed that patients newly starting treatment with a NOAC had significantly lower rates of major bleeding than those starting treatment with warfarin, which was 4.6% per year versus 2.35% per year for apixiban, 3.38% per year for dabigatran, and 4.57% per year for rivaroxaban in the first study.

In the second study (Eur Heart J. 2015;36:1085.P6215) the respective adjusted hazard ratios for bleeding risk were 1.094, 0.747 and 0.679, comparing rivaroxaban, apixaban, and dabigatran against warfarin.

Other data gleaned from separate U.S. EMRs suggested that apixaban was associated with fewer bleeding-related hospital readmissions than either rivaroxaban or dabigatran in hospitalized patients with nonvalvular atrial fibrillation (Eur Heart J. 2015;36: 1085.P6211).

Dr. Lip presented 6-month follow-up data on more than 60,000 patients with nonvalvular atrial fibrillation who were treated with one of the three NOACs that was recorded in a U.S. medical claims database (Eur Heart J. 2015;36:339.1975). Most of the patients were treated with rivaroxaban (50.6%), with 34.8% treated with dabigatran and 14.6% with apixaban. Unadjusted data showed that the rates of major bleeding were 20.2% per year, 13.2% per year, and 14.5% per year, respectively.

Dr. Lip observed that, after adjusting the data, patients taking dabigatran had higher rates of clinically relevant nonmajor gastrointestinal bleeding (HR =1.24), and that those taking rivaroxaban were more likely to have major (HR = 3.6), clinically relevant nonmajor (HR = 1.43), or any bleeding (HR = 1.41) when compared with apixaban users.

“Larger cohort studies and longer follow-up data of general nonvalvular atrial fibrillation populations will be needed to confirm these early observations,” Dr. Lip concluded.

While real-world research of course has its limitations and cannot replace clinical trial findings as a means to accurately compare the clinical efficacy or safety profiles of different medicines, such studies do provide information that can help inform clinical practice.

“With 10 million people in Europe alone affected by atrial fibrillation, a number that is only expected to increase, real-world insights on routine anticoagulation management in everyday clinical practice is increasingly important for physicians and patients,” Dr. Camm noted in a media release on the XANTUS trial issued by the European Society of Cardiology.

Dr. Camm added: “These real-world insights from XANTAS complement and expand on what we already know from clinical trials, and provide physicians with reassurance to prescribe rivaroxaban as an effective and well-tolerated treatment option for the broad range of patients with atrial fibrillation seen in their everyday practice.”

The XANTUS and PMSS studies were supported by Bayer HealthCare and Janssen. The other studies mentioned were supported by Bristol-Myers Squibb and Pfizer. Dr. Camm disclosed acting as a consultant for Bayer Healthcare and other health care companies. Dr. Lip disclosed acting as a consultant for Bayer Healthcare, Bristol-Myers Squibb, and Pfizer as well as other health care companies.

LONDON – The factor Xa inhibitor rivaroxaban was associated with low rates of bleeding and stroke in two observational studies that included more than 45,000 people with nonvalvular atrial fibrillation.

The XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) study involved 6,784 individuals treated at centers in Europe, Canada, and Israel. The incidence of major bleeding was 2.1% per year and the risk of stroke was 0.7% per year. Rates of fatal, critical organ, and intracranial bleeding were also low at 0.2%, 0.7%, and 0.4% per year, respectively.

Sara Freeman/Frontline Medical News

“The rates of stroke and systemic embolism, all strokes and gastrointestinal bleeding were markedly lower in XANTUS in comparison to ROCKET-AF,” noted Dr. John Camm who presented the XANTUS study findings at the annual congress of the European Society of Cardiology. “Major bleeding was also largely reduced in XANTUS, however the death rate and intracranial hemorrhage rate was similar,” he added.

Dr. Camm, who is professor of clinical cardiology at St George’s Hospital in London, noted that the patient populations and the design of the XANTUS study and phase III ROCKET-AF trial (N Engl J Med. 2011;365:883-91) were slightly different. Patients in the single-arm, prospective, observational XANTUS study were recruited from routine primary care practices and had an overall lower risk of stroke than those enrolled in the randomized, double-blind, controlled clinical trial who were at more moderate to high risk respective CHADS₂ scores of 2.0 and 3.5. The incidence of major bleeding was also slightly higher in the ROCKET-AF, at 3.6% per year, which was similar to that seen with warfarin (3.4%; P = .58), the active comparator used.

Nevertheless, the findings of the XANTUS study, which were published online simultaneously with their presentation at the conference (Eur Heart J. Sep 1. doi: 10.1093/eurheartj/ehv466), highlight the “real-world” safety of rivaroxaban, Dr. Camm said.

Results from the separate PMSS (Post-Marketing Safety Surveillance) study reported in a poster at the meeting were similar. The PMSS study is being conducted in the United States and is an ongoing, retrospective, 5-year, observational study of more than 39,000 patients with nonvalvular atrial fibrillation. At 2 years follow-up, the incidence of major bleeding was 2.89% per year and the incidence of fatal bleeding was 0.1% per year (Eur Heart J. 2015;36:687.P4066).

“Real-world research is an essential complement to clinical trials and helps inform treatment decisions,” PMSS study investigator Dr. Frank Peacock said in a press release issued by Janssen. Dr. Peacock, who is professor of emergency medicine at Baylor College of Medicine in Houston, added, “These studies confirm the safety profile of rivaroxaban in real-world settings around the globe.”

The XANTUS and PMSS studies are part of a large postlicensing program and were respectively designed to meet European Medicines Agency and U.S. Food and Drug Administration requirements on the long-term monitoring of medicines. There are also similar programs running in other world regions, such as XANTUS-EL and XANAP.

Other real-world data gleaned from electronic medical records (EMRs) comparing the potential bleeding risks of the factor Xa inhibitor apixaban (Eliquis) versus other available non–vitamin K antagonists (NOACs) including rivaroxaban and the direct thrombin inhibitor dabigatran (Pradaxa) were reported in several posters supported by Bristol-Myers Squibb and Pfizer and in an oral presentation given by Dr. Gregory Lip of the University of Birmingham, England.

Two of the posters reported data from retrospective analyses of different United States EMRs of 29,338 and 35, 757 patients, respectively, with nonvalvular atrial fibrillation newly started on a NOAC or warfarin in 2013 or 2014. Most were started on warfarin (43.3%/69.6%), followed by rivaroxaban (34.3%/17.9%), dabigatran (14.2%/6.8%), and apixaban (8.2%/5.7%).

Results of the first study (Eur Heart J. 2015;36:1085.P6217) showed that patients newly starting treatment with a NOAC had significantly lower rates of major bleeding than those starting treatment with warfarin, which was 4.6% per year versus 2.35% per year for apixiban, 3.38% per year for dabigatran, and 4.57% per year for rivaroxaban in the first study.

In the second study (Eur Heart J. 2015;36:1085.P6215) the respective adjusted hazard ratios for bleeding risk were 1.094, 0.747 and 0.679, comparing rivaroxaban, apixaban, and dabigatran against warfarin.

Other data gleaned from separate U.S. EMRs suggested that apixaban was associated with fewer bleeding-related hospital readmissions than either rivaroxaban or dabigatran in hospitalized patients with nonvalvular atrial fibrillation (Eur Heart J. 2015;36: 1085.P6211).

Dr. Lip presented 6-month follow-up data on more than 60,000 patients with nonvalvular atrial fibrillation who were treated with one of the three NOACs that was recorded in a U.S. medical claims database (Eur Heart J. 2015;36:339.1975). Most of the patients were treated with rivaroxaban (50.6%), with 34.8% treated with dabigatran and 14.6% with apixaban. Unadjusted data showed that the rates of major bleeding were 20.2% per year, 13.2% per year, and 14.5% per year, respectively.

Dr. Lip observed that, after adjusting the data, patients taking dabigatran had higher rates of clinically relevant nonmajor gastrointestinal bleeding (HR =1.24), and that those taking rivaroxaban were more likely to have major (HR = 3.6), clinically relevant nonmajor (HR = 1.43), or any bleeding (HR = 1.41) when compared with apixaban users.

“Larger cohort studies and longer follow-up data of general nonvalvular atrial fibrillation populations will be needed to confirm these early observations,” Dr. Lip concluded.

While real-world research of course has its limitations and cannot replace clinical trial findings as a means to accurately compare the clinical efficacy or safety profiles of different medicines, such studies do provide information that can help inform clinical practice.

“With 10 million people in Europe alone affected by atrial fibrillation, a number that is only expected to increase, real-world insights on routine anticoagulation management in everyday clinical practice is increasingly important for physicians and patients,” Dr. Camm noted in a media release on the XANTUS trial issued by the European Society of Cardiology.

Dr. Camm added: “These real-world insights from XANTAS complement and expand on what we already know from clinical trials, and provide physicians with reassurance to prescribe rivaroxaban as an effective and well-tolerated treatment option for the broad range of patients with atrial fibrillation seen in their everyday practice.”

The XANTUS and PMSS studies were supported by Bayer HealthCare and Janssen. The other studies mentioned were supported by Bristol-Myers Squibb and Pfizer. Dr. Camm disclosed acting as a consultant for Bayer Healthcare and other health care companies. Dr. Lip disclosed acting as a consultant for Bayer Healthcare, Bristol-Myers Squibb, and Pfizer as well as other health care companies.

Eculizumab therapy led to “acceptable” outcomes among pregnant women with paroxysmal nocturnal hemoglobinuria, investigators reported Sept. 9 in the New England Journal of Medicine.

No woman who received eculizumab died while pregnant or within 6 months of delivery; historic mortality rates for these patients are 8%-20%, said Dr. Richard Kelly at St. James’s University Hospital in Leeds, England, and his associates. Treatment with the monoclonal antibody, “has reduced mortality and morbidity associated with PNH and has allowed patients who were previously severely affected to lead a relatively normal life.”

The fetal death rate was 4%, resembling rates of 4%-9% from the era before eculizumab, the researchers said. The rate of premature births also was high (29%) as a result of preeclampsia, suspected intrauterine growth retardation, maternal thrombocytopenia, and slowed fetal movements, they said.

Paroxysmal nocturnal hemoglobinuria is a rare, chronic stem-cell disease in which complement-mediated intravascular hemolysis causes anemia, fatigue, and venous thromboembolism (Adv Exp Med Biol. 2013;735:155-72.). Increased complement activation during pregnancy intensifies the risk of severe hemolytic anemia, fetal morbidity, and fetal mortality for women with PNH. Eculizumab blocks terminal complement activation by binding complement protein C5, and has improved PNH symptoms to the extent that treated women are more likely to consider pregnancy than in the past.

Dr. Kelly and his associates surveyed members of the International PNH Interest Group to study pregnancy outcomes among these women (N Engl J. Med. 2015;373:1032-9). A total of 80% of clinicians responded, reporting data for 75 pregnancies among 61 women, the investigators said. All patients had PNH diagnosed by flow cytometry, and 61% had begun eculizumab therapy before conception. Median age at first pregnancy was 29 years, with a range of 18 to 40 years. The patients received weekly 600-mg IV infusions for 4 weeks, followed by 900 mg every 14 days. Clinicians increased the dose or treatment frequency at their own discretion if patients showed signs of breakthrough intravascular hemolysis.

Two women experienced thrombotic events during treatment, both of which happened soon after delivery. One was a lower-limb deep venous thrombosis, but the other occurred after a patient received a plasma infusion for postpartum hemorrhage. “Plasma contains high levels of complement and can overcome the effects of eculizumab and thereby render the patient susceptible to complications of PNH,” noted the investigators. “The use of plasma should thus be avoided if possible.” Ten samples of breast milk were negative for eculizumab, they added.

Dr. Kelly and 14 of 15 coauthors reported financial relationships outside this work with Alexion Pharmaceuticals, the maker of eculizumab. One coauthor also reported grant support outside this work from Alnylam Pharmaceuticals, Novartis, and Ra Pharma.

Eculizumab therapy led to “acceptable” outcomes among pregnant women with paroxysmal nocturnal hemoglobinuria, investigators reported Sept. 9 in the New England Journal of Medicine.

No woman who received eculizumab died while pregnant or within 6 months of delivery; historic mortality rates for these patients are 8%-20%, said Dr. Richard Kelly at St. James’s University Hospital in Leeds, England, and his associates. Treatment with the monoclonal antibody, “has reduced mortality and morbidity associated with PNH and has allowed patients who were previously severely affected to lead a relatively normal life.”

The fetal death rate was 4%, resembling rates of 4%-9% from the era before eculizumab, the researchers said. The rate of premature births also was high (29%) as a result of preeclampsia, suspected intrauterine growth retardation, maternal thrombocytopenia, and slowed fetal movements, they said.

Paroxysmal nocturnal hemoglobinuria is a rare, chronic stem-cell disease in which complement-mediated intravascular hemolysis causes anemia, fatigue, and venous thromboembolism (Adv Exp Med Biol. 2013;735:155-72.). Increased complement activation during pregnancy intensifies the risk of severe hemolytic anemia, fetal morbidity, and fetal mortality for women with PNH. Eculizumab blocks terminal complement activation by binding complement protein C5, and has improved PNH symptoms to the extent that treated women are more likely to consider pregnancy than in the past.

Dr. Kelly and his associates surveyed members of the International PNH Interest Group to study pregnancy outcomes among these women (N Engl J. Med. 2015;373:1032-9). A total of 80% of clinicians responded, reporting data for 75 pregnancies among 61 women, the investigators said. All patients had PNH diagnosed by flow cytometry, and 61% had begun eculizumab therapy before conception. Median age at first pregnancy was 29 years, with a range of 18 to 40 years. The patients received weekly 600-mg IV infusions for 4 weeks, followed by 900 mg every 14 days. Clinicians increased the dose or treatment frequency at their own discretion if patients showed signs of breakthrough intravascular hemolysis.

Two women experienced thrombotic events during treatment, both of which happened soon after delivery. One was a lower-limb deep venous thrombosis, but the other occurred after a patient received a plasma infusion for postpartum hemorrhage. “Plasma contains high levels of complement and can overcome the effects of eculizumab and thereby render the patient susceptible to complications of PNH,” noted the investigators. “The use of plasma should thus be avoided if possible.” Ten samples of breast milk were negative for eculizumab, they added.

Dr. Kelly and 14 of 15 coauthors reported financial relationships outside this work with Alexion Pharmaceuticals, the maker of eculizumab. One coauthor also reported grant support outside this work from Alnylam Pharmaceuticals, Novartis, and Ra Pharma.

Eculizumab therapy led to “acceptable” outcomes among pregnant women with paroxysmal nocturnal hemoglobinuria, investigators reported Sept. 9 in the New England Journal of Medicine.

No woman who received eculizumab died while pregnant or within 6 months of delivery; historic mortality rates for these patients are 8%-20%, said Dr. Richard Kelly at St. James’s University Hospital in Leeds, England, and his associates. Treatment with the monoclonal antibody, “has reduced mortality and morbidity associated with PNH and has allowed patients who were previously severely affected to lead a relatively normal life.”

The fetal death rate was 4%, resembling rates of 4%-9% from the era before eculizumab, the researchers said. The rate of premature births also was high (29%) as a result of preeclampsia, suspected intrauterine growth retardation, maternal thrombocytopenia, and slowed fetal movements, they said.

Paroxysmal nocturnal hemoglobinuria is a rare, chronic stem-cell disease in which complement-mediated intravascular hemolysis causes anemia, fatigue, and venous thromboembolism (Adv Exp Med Biol. 2013;735:155-72.). Increased complement activation during pregnancy intensifies the risk of severe hemolytic anemia, fetal morbidity, and fetal mortality for women with PNH. Eculizumab blocks terminal complement activation by binding complement protein C5, and has improved PNH symptoms to the extent that treated women are more likely to consider pregnancy than in the past.

Dr. Kelly and his associates surveyed members of the International PNH Interest Group to study pregnancy outcomes among these women (N Engl J. Med. 2015;373:1032-9). A total of 80% of clinicians responded, reporting data for 75 pregnancies among 61 women, the investigators said. All patients had PNH diagnosed by flow cytometry, and 61% had begun eculizumab therapy before conception. Median age at first pregnancy was 29 years, with a range of 18 to 40 years. The patients received weekly 600-mg IV infusions for 4 weeks, followed by 900 mg every 14 days. Clinicians increased the dose or treatment frequency at their own discretion if patients showed signs of breakthrough intravascular hemolysis.

Two women experienced thrombotic events during treatment, both of which happened soon after delivery. One was a lower-limb deep venous thrombosis, but the other occurred after a patient received a plasma infusion for postpartum hemorrhage. “Plasma contains high levels of complement and can overcome the effects of eculizumab and thereby render the patient susceptible to complications of PNH,” noted the investigators. “The use of plasma should thus be avoided if possible.” Ten samples of breast milk were negative for eculizumab, they added.

Dr. Kelly and 14 of 15 coauthors reported financial relationships outside this work with Alexion Pharmaceuticals, the maker of eculizumab. One coauthor also reported grant support outside this work from Alnylam Pharmaceuticals, Novartis, and Ra Pharma.

The first recipient of CTL019 for advanced refractory multiple myeloma achieved a durable complete response without developing cytokine release syndrome, according to a study published Sept. 9 in the New England Journal of Medicine.

“Twelve months after transplantation, the patient had no evidence of monoclonal immunoglobulin on serum and urine immunofixation and no clinical signs or symptoms of multiple myeloma,” said Dr. Alfred Garfall and his associates at the University of Pennsylvania in Philadelphia. “This response was achieved despite the absence of CD19 expression in 99.95% of the patient’s neoplastic plasma cells.”

Courtesy Wikimedia Commons/KGH/Creative Commons License

CTL019 consists of autologous T cells modified to express an anti-CD19 chimeric antigen receptor (CAR) from a lentiviral vector. The cell therapy has yielded promising results in relapsed/refractory CLL and ALL,but was overlooked in MM because it was thought to infrequently express CD19, the researchers said.

“Several reports, however, have suggested that a minor component of the MM clone with drug-resistant, disease-propagating properties has a B-cell (i.e., CD19-positive) phenotype,” they noted. “In addition, our unpublished observations suggest that neoplastic plasma cells express low levels of CD19” (N Engl J Med. 2015 Sep 9;373:1040-7).

In response, they designed a pilot trial of adults whose MM relapsed or progressed within a year after initial autologous stem cell transplant. The first participant, a 43-year-old woman with IgA kappa MM, partially responded to lenalidomide, bortezomib, and dexamethasone but progressed when therapy was paused to collect stem cells for transplant. She then partially responded to cisplatin, doxorubicin, cyclophosphamide, and etoposide followed by high-dose melphalan and ASCT, but progressed again and continued to worsen despite a total of nine lines of therapy. A bone marrow sample revealed more than 95% plasma cells when the patient began the CTL019 trial, the researchers said.

For the study, the patient received a lower melphalan dose (140 mg/m² of body surface area), followed by ASCT, CTL019 starting 2 weeks later, and maintenance lenalidomide. On day 100, her tumor burden had dropped by 5-log10, the researchers said. She also did not develop cytokine release syndrome, they added.

So far, 10 patients have been treated on study, of whom six remain progression free, according to the investigators. “The only additional CTL019-attributable toxic effects observed have been one instance of grade 1 cytokine release syndrome and one instance of grade 3 enterocolitis due to autologous graft-versus-host disease,” they reported.

Novartis supported the study and approved the manuscript. The work was also funded by the National Institutes of Health, the International Society for Advancement of Cytometry, the University of Pennsylvania Institute or Translational Medicine and Therapeutics, and a Conquer Cancer Foundation Young Investigator Award. The University of Pennsylvania has licensed technologies involved in this trial to Novartis. Several scientists involved in this trial hold patents for these technologies. As a result of the licensing relationship with Novartis, the University of Pennsylvania receives significant financial benefit, and these inventors have benefited financially or may benefit in the future.

The first recipient of CTL019 for advanced refractory multiple myeloma achieved a durable complete response without developing cytokine release syndrome, according to a study published Sept. 9 in the New England Journal of Medicine.

“Twelve months after transplantation, the patient had no evidence of monoclonal immunoglobulin on serum and urine immunofixation and no clinical signs or symptoms of multiple myeloma,” said Dr. Alfred Garfall and his associates at the University of Pennsylvania in Philadelphia. “This response was achieved despite the absence of CD19 expression in 99.95% of the patient’s neoplastic plasma cells.”

Courtesy Wikimedia Commons/KGH/Creative Commons License

CTL019 consists of autologous T cells modified to express an anti-CD19 chimeric antigen receptor (CAR) from a lentiviral vector. The cell therapy has yielded promising results in relapsed/refractory CLL and ALL,but was overlooked in MM because it was thought to infrequently express CD19, the researchers said.

“Several reports, however, have suggested that a minor component of the MM clone with drug-resistant, disease-propagating properties has a B-cell (i.e., CD19-positive) phenotype,” they noted. “In addition, our unpublished observations suggest that neoplastic plasma cells express low levels of CD19” (N Engl J Med. 2015 Sep 9;373:1040-7).

In response, they designed a pilot trial of adults whose MM relapsed or progressed within a year after initial autologous stem cell transplant. The first participant, a 43-year-old woman with IgA kappa MM, partially responded to lenalidomide, bortezomib, and dexamethasone but progressed when therapy was paused to collect stem cells for transplant. She then partially responded to cisplatin, doxorubicin, cyclophosphamide, and etoposide followed by high-dose melphalan and ASCT, but progressed again and continued to worsen despite a total of nine lines of therapy. A bone marrow sample revealed more than 95% plasma cells when the patient began the CTL019 trial, the researchers said.

For the study, the patient received a lower melphalan dose (140 mg/m² of body surface area), followed by ASCT, CTL019 starting 2 weeks later, and maintenance lenalidomide. On day 100, her tumor burden had dropped by 5-log10, the researchers said. She also did not develop cytokine release syndrome, they added.

So far, 10 patients have been treated on study, of whom six remain progression free, according to the investigators. “The only additional CTL019-attributable toxic effects observed have been one instance of grade 1 cytokine release syndrome and one instance of grade 3 enterocolitis due to autologous graft-versus-host disease,” they reported.

Novartis supported the study and approved the manuscript. The work was also funded by the National Institutes of Health, the International Society for Advancement of Cytometry, the University of Pennsylvania Institute or Translational Medicine and Therapeutics, and a Conquer Cancer Foundation Young Investigator Award. The University of Pennsylvania has licensed technologies involved in this trial to Novartis. Several scientists involved in this trial hold patents for these technologies. As a result of the licensing relationship with Novartis, the University of Pennsylvania receives significant financial benefit, and these inventors have benefited financially or may benefit in the future.

The first recipient of CTL019 for advanced refractory multiple myeloma achieved a durable complete response without developing cytokine release syndrome, according to a study published Sept. 9 in the New England Journal of Medicine.

“Twelve months after transplantation, the patient had no evidence of monoclonal immunoglobulin on serum and urine immunofixation and no clinical signs or symptoms of multiple myeloma,” said Dr. Alfred Garfall and his associates at the University of Pennsylvania in Philadelphia. “This response was achieved despite the absence of CD19 expression in 99.95% of the patient’s neoplastic plasma cells.”

Courtesy Wikimedia Commons/KGH/Creative Commons License

CTL019 consists of autologous T cells modified to express an anti-CD19 chimeric antigen receptor (CAR) from a lentiviral vector. The cell therapy has yielded promising results in relapsed/refractory CLL and ALL,but was overlooked in MM because it was thought to infrequently express CD19, the researchers said.

“Several reports, however, have suggested that a minor component of the MM clone with drug-resistant, disease-propagating properties has a B-cell (i.e., CD19-positive) phenotype,” they noted. “In addition, our unpublished observations suggest that neoplastic plasma cells express low levels of CD19” (N Engl J Med. 2015 Sep 9;373:1040-7).

In response, they designed a pilot trial of adults whose MM relapsed or progressed within a year after initial autologous stem cell transplant. The first participant, a 43-year-old woman with IgA kappa MM, partially responded to lenalidomide, bortezomib, and dexamethasone but progressed when therapy was paused to collect stem cells for transplant. She then partially responded to cisplatin, doxorubicin, cyclophosphamide, and etoposide followed by high-dose melphalan and ASCT, but progressed again and continued to worsen despite a total of nine lines of therapy. A bone marrow sample revealed more than 95% plasma cells when the patient began the CTL019 trial, the researchers said.

For the study, the patient received a lower melphalan dose (140 mg/m² of body surface area), followed by ASCT, CTL019 starting 2 weeks later, and maintenance lenalidomide. On day 100, her tumor burden had dropped by 5-log10, the researchers said. She also did not develop cytokine release syndrome, they added.

So far, 10 patients have been treated on study, of whom six remain progression free, according to the investigators. “The only additional CTL019-attributable toxic effects observed have been one instance of grade 1 cytokine release syndrome and one instance of grade 3 enterocolitis due to autologous graft-versus-host disease,” they reported.

Novartis supported the study and approved the manuscript. The work was also funded by the National Institutes of Health, the International Society for Advancement of Cytometry, the University of Pennsylvania Institute or Translational Medicine and Therapeutics, and a Conquer Cancer Foundation Young Investigator Award. The University of Pennsylvania has licensed technologies involved in this trial to Novartis. Several scientists involved in this trial hold patents for these technologies. As a result of the licensing relationship with Novartis, the University of Pennsylvania receives significant financial benefit, and these inventors have benefited financially or may benefit in the future.

Editor’s note: This article first appeared on SHM’s “The Hospital Leader” blog.

Patient satisfaction survey performance is becoming increasingly important for hospitals, because the ratings are being used by payers in pay-for-performance programs more and more (including the CMS Hospital Value-Based Purchasing program). CMS also recently released its “Five-Star Quality Rating System” for hospitals, which publicly grades hospitals, using one to five stars, based on their patient satisfaction scores.

How Did Hospitals Do in Medicare’s Patient Quality Ratings?

Unfortunately, there is little literature to guide physicians on exactly HOW to improve patient satisfaction scores for themselves or their groups. A recent publication in the Journal of Hospital Medicine found a feasible and effective intervention to improve patient satisfaction scores among trainees, the methodology of which could easily be applied to hospitalists.

Gaurav Banka, MD, a former internal medicine resident (and current cardiology fellow) at UCLA Hospital, was interviewed about his team’s recent publication in the Journal of Hospital Medicine. In the interview, he opined about “improving patient satisfaction through resident education, feedback, and incentives.” The study he published found that this combination of interventions among internal medicine residents improved relevant HCAHPS scores by approximately 8%.

The following are excerpts from a Q&A session I had with Dr. Banka:

Question: Can you briefly summarize the intervention(s)?

Answer: There were three total interventions put in place simultaneously: an educational conference on best practices in patient communication, a recognition-reward program (recognition within the department and a movie package for high performers), and real-time feedback to the residents from their patients via a survey. The last component was the most impactful to the residents. Patients were randomly surveyed on how their residents were communicating with them, and the results were sent to the resident for review and self-reflection within weeks.

Q: How did you become interested in resident interventions to improve HCAHPS?

A: I noticed as an intern [that] there was almost no emphasis placed on patient communication skills, and there was almost no feedback given to residents on how they were performing. I felt that this was a very important piece of feedback that residents were lacking and was very interested in creating a program that would help them learn new communication skills and get feedback on how they were doing.

Q: How should hospitalists use this study information to change their practice?

A: Hospital medicine programs should have some way to measure and give feedback to individual hospitalists on what the patient is experiencing with respect to communication. The intervention from this study should be easily scalable to any practice. There was almost no cost associated with the patient survey distribution, and it gave incredibly valuable individualized feedback about communication skills directly from the patients themselves. It should be feasible to implement this type of audit and feedback within any size hospital medicine program.

Q: Were there any unexpected findings in your study?

A: We were surprised at how much of an impact it had on HCAHPS scores. Not only did it impact physician communication ratings, but [it] also had an impressive impact on overall hospital ratings.

Q: Where does this take us with respect to future research efforts?

A: Our team is now working on expanding this program to other residency programs, as well as expanding it to attending physicians, within and outside the department of medicine.

In summary, Dr. Banka’s team found this relatively simple intervention was able to sizably improve the HCAHPS scores of recipient providers. Such interventions should be seriously considered by hospital medicine programs looking to improve their publicly reported patient satisfaction scores.

Editor’s note: This article first appeared on SHM’s “The Hospital Leader” blog.

Patient satisfaction survey performance is becoming increasingly important for hospitals, because the ratings are being used by payers in pay-for-performance programs more and more (including the CMS Hospital Value-Based Purchasing program). CMS also recently released its “Five-Star Quality Rating System” for hospitals, which publicly grades hospitals, using one to five stars, based on their patient satisfaction scores.

How Did Hospitals Do in Medicare’s Patient Quality Ratings?

Unfortunately, there is little literature to guide physicians on exactly HOW to improve patient satisfaction scores for themselves or their groups. A recent publication in the Journal of Hospital Medicine found a feasible and effective intervention to improve patient satisfaction scores among trainees, the methodology of which could easily be applied to hospitalists.

Gaurav Banka, MD, a former internal medicine resident (and current cardiology fellow) at UCLA Hospital, was interviewed about his team’s recent publication in the Journal of Hospital Medicine. In the interview, he opined about “improving patient satisfaction through resident education, feedback, and incentives.” The study he published found that this combination of interventions among internal medicine residents improved relevant HCAHPS scores by approximately 8%.

The following are excerpts from a Q&A session I had with Dr. Banka:

Question: Can you briefly summarize the intervention(s)?

Answer: There were three total interventions put in place simultaneously: an educational conference on best practices in patient communication, a recognition-reward program (recognition within the department and a movie package for high performers), and real-time feedback to the residents from their patients via a survey. The last component was the most impactful to the residents. Patients were randomly surveyed on how their residents were communicating with them, and the results were sent to the resident for review and self-reflection within weeks.

Q: How did you become interested in resident interventions to improve HCAHPS?

A: I noticed as an intern [that] there was almost no emphasis placed on patient communication skills, and there was almost no feedback given to residents on how they were performing. I felt that this was a very important piece of feedback that residents were lacking and was very interested in creating a program that would help them learn new communication skills and get feedback on how they were doing.

Q: How should hospitalists use this study information to change their practice?

A: Hospital medicine programs should have some way to measure and give feedback to individual hospitalists on what the patient is experiencing with respect to communication. The intervention from this study should be easily scalable to any practice. There was almost no cost associated with the patient survey distribution, and it gave incredibly valuable individualized feedback about communication skills directly from the patients themselves. It should be feasible to implement this type of audit and feedback within any size hospital medicine program.

Q: Were there any unexpected findings in your study?

A: We were surprised at how much of an impact it had on HCAHPS scores. Not only did it impact physician communication ratings, but [it] also had an impressive impact on overall hospital ratings.

Q: Where does this take us with respect to future research efforts?

A: Our team is now working on expanding this program to other residency programs, as well as expanding it to attending physicians, within and outside the department of medicine.

In summary, Dr. Banka’s team found this relatively simple intervention was able to sizably improve the HCAHPS scores of recipient providers. Such interventions should be seriously considered by hospital medicine programs looking to improve their publicly reported patient satisfaction scores.

Editor’s note: This article first appeared on SHM’s “The Hospital Leader” blog.

Patient satisfaction survey performance is becoming increasingly important for hospitals, because the ratings are being used by payers in pay-for-performance programs more and more (including the CMS Hospital Value-Based Purchasing program). CMS also recently released its “Five-Star Quality Rating System” for hospitals, which publicly grades hospitals, using one to five stars, based on their patient satisfaction scores.

How Did Hospitals Do in Medicare’s Patient Quality Ratings?

Unfortunately, there is little literature to guide physicians on exactly HOW to improve patient satisfaction scores for themselves or their groups. A recent publication in the Journal of Hospital Medicine found a feasible and effective intervention to improve patient satisfaction scores among trainees, the methodology of which could easily be applied to hospitalists.

Gaurav Banka, MD, a former internal medicine resident (and current cardiology fellow) at UCLA Hospital, was interviewed about his team’s recent publication in the Journal of Hospital Medicine. In the interview, he opined about “improving patient satisfaction through resident education, feedback, and incentives.” The study he published found that this combination of interventions among internal medicine residents improved relevant HCAHPS scores by approximately 8%.

The following are excerpts from a Q&A session I had with Dr. Banka:

Question: Can you briefly summarize the intervention(s)?

Answer: There were three total interventions put in place simultaneously: an educational conference on best practices in patient communication, a recognition-reward program (recognition within the department and a movie package for high performers), and real-time feedback to the residents from their patients via a survey. The last component was the most impactful to the residents. Patients were randomly surveyed on how their residents were communicating with them, and the results were sent to the resident for review and self-reflection within weeks.

Q: How did you become interested in resident interventions to improve HCAHPS?

A: I noticed as an intern [that] there was almost no emphasis placed on patient communication skills, and there was almost no feedback given to residents on how they were performing. I felt that this was a very important piece of feedback that residents were lacking and was very interested in creating a program that would help them learn new communication skills and get feedback on how they were doing.

Q: How should hospitalists use this study information to change their practice?

A: Hospital medicine programs should have some way to measure and give feedback to individual hospitalists on what the patient is experiencing with respect to communication. The intervention from this study should be easily scalable to any practice. There was almost no cost associated with the patient survey distribution, and it gave incredibly valuable individualized feedback about communication skills directly from the patients themselves. It should be feasible to implement this type of audit and feedback within any size hospital medicine program.

Q: Were there any unexpected findings in your study?

A: We were surprised at how much of an impact it had on HCAHPS scores. Not only did it impact physician communication ratings, but [it] also had an impressive impact on overall hospital ratings.

Q: Where does this take us with respect to future research efforts?

A: Our team is now working on expanding this program to other residency programs, as well as expanding it to attending physicians, within and outside the department of medicine.

In summary, Dr. Banka’s team found this relatively simple intervention was able to sizably improve the HCAHPS scores of recipient providers. Such interventions should be seriously considered by hospital medicine programs looking to improve their publicly reported patient satisfaction scores.

Understanding and improving the patient care experience has become a vital component of delivering high quality care. According to a new survey of American Society for Quality (ASQ) healthcare quality experts, more than 80% of respondents said improving communications between caregivers and patients and easing access to treatment across the entire continuum of care should be top priorities for improving patient experience. For Hill Country Memorial (HCM) in Fredericksburg, Texas, winner of the Malcolm Baldrige National Quality Award, accomplishing this kind of top-level patient experience performance involved engaging physicians—particularly hospitalists—using voice of the customer (VOC) input.

HCM did not achieve overnight success, however; instead, the facility achieved year-over-year improvement in finance and growth, patient experience, quality of care, and workforce environment and engagement (see Figure 1).

HCM developed a systematic VOC input-to-action process in which listening and learning methods during annual planning led them to institute a hospitalist program. Results included:

• Improved access to primary care, achieved by increasing the physicians’ hours of availability in their clinics, and improved work-life balance, enhancing engagement and alignment of the medical staff and HCM;
• Reductions in delays in admissions, discharges, and length of stay; and
• Real-time review and management of clinical data, not just during the daily rounding as had been done previously.

One of the major hurdles in the way of achieving patient satisfaction, according to the ASQ patient experience survey, is care that is fragmented and uncoordinated because of communication issues. HCM has overcome those hurdles using strategies such as a daily afternoon huddle in which hospitalists meet with a multidisciplinary team so that everyone understands patient action plans and current concerns. The process of discharge planning begins in these huddles so that more complex issues are initiated on day one of the hospital stay.

A new rounding communication process, called GIFT for greet, inform, find out, and time, has dramatically improved patient satisfaction and engagement. GIFT enables hospitalists to greet a patient with a personal introduction and an explanation of their position and responsibilities. Hospitalists always sit while engaging the patient, and they make it a point to acknowledge not only the patient but everyone present in the room. Personalized “baseball cards” featuring the hospitalist’s background, including personal interests and hobbies, are handed out to patients or family members. Hospitalists take time to inform the patient and appropriate family members and caregivers of all diagnostic test results and the clinical response of treatment to date. Treatment plans and further diagnostic tests or procedures are discussed. A report of all consultants who have joined or will be joining in the care, along with their roles in the treatment planned, is fully vetted.

One key to a successful patient experience is discovering the concerns of the patient, family members, friends, and caregivers. Emotional issues become as important as the physical needs of the patient; these are openly addressed. Ask not “What’s the matter?” but instead “What matters to you?”

Timing the hospitalist’s return to see the patient and the anticipated date of transition of care is the last item in the rounding interaction. The date should be as accurate as possible to reduce patient anxiety and help the patient understand that the hospitalist really cares.

The hospitalist program has also strengthened the relationship between nurses and physicians. Nurses know the hospitalists’ practice patterns well, which allows them to help manage patient interactions and minimize patient anxiety and frustration. The physician-patient relationship is reinforced when nurse leaders include hospitalist satisfaction questions during daily rounding to identify concerns that can be clarified or resolved in real time.

The systematic VOC approach has enabled HCM to design, manage, and improve its key work process at multiple levels of the organization. These processes are reviewed and refined periodically to respond to the changing healthcare environment and stay focused on creating value for customers.

Chip Caldwell is chairman of Caldwell Butler, a firm specializing in coaching organizations to achieve world class performance in margin improvement, patient experience, physician/clinical enterprise, and capacity optimization. Jayne Pope, MBA, RN, is CEO of Hill Country Memorial Hospital in Fredericksburg, Texas. James Partin, MD, is CMO at Hill Country Memorial.

Understanding and improving the patient care experience has become a vital component of delivering high quality care. According to a new survey of American Society for Quality (ASQ) healthcare quality experts, more than 80% of respondents said improving communications between caregivers and patients and easing access to treatment across the entire continuum of care should be top priorities for improving patient experience. For Hill Country Memorial (HCM) in Fredericksburg, Texas, winner of the Malcolm Baldrige National Quality Award, accomplishing this kind of top-level patient experience performance involved engaging physicians—particularly hospitalists—using voice of the customer (VOC) input.

HCM did not achieve overnight success, however; instead, the facility achieved year-over-year improvement in finance and growth, patient experience, quality of care, and workforce environment and engagement (see Figure 1).

HCM developed a systematic VOC input-to-action process in which listening and learning methods during annual planning led them to institute a hospitalist program. Results included:

• Improved access to primary care, achieved by increasing the physicians’ hours of availability in their clinics, and improved work-life balance, enhancing engagement and alignment of the medical staff and HCM;
• Reductions in delays in admissions, discharges, and length of stay; and
• Real-time review and management of clinical data, not just during the daily rounding as had been done previously.

One of the major hurdles in the way of achieving patient satisfaction, according to the ASQ patient experience survey, is care that is fragmented and uncoordinated because of communication issues. HCM has overcome those hurdles using strategies such as a daily afternoon huddle in which hospitalists meet with a multidisciplinary team so that everyone understands patient action plans and current concerns. The process of discharge planning begins in these huddles so that more complex issues are initiated on day one of the hospital stay.

A new rounding communication process, called GIFT for greet, inform, find out, and time, has dramatically improved patient satisfaction and engagement. GIFT enables hospitalists to greet a patient with a personal introduction and an explanation of their position and responsibilities. Hospitalists always sit while engaging the patient, and they make it a point to acknowledge not only the patient but everyone present in the room. Personalized “baseball cards” featuring the hospitalist’s background, including personal interests and hobbies, are handed out to patients or family members. Hospitalists take time to inform the patient and appropriate family members and caregivers of all diagnostic test results and the clinical response of treatment to date. Treatment plans and further diagnostic tests or procedures are discussed. A report of all consultants who have joined or will be joining in the care, along with their roles in the treatment planned, is fully vetted.

One key to a successful patient experience is discovering the concerns of the patient, family members, friends, and caregivers. Emotional issues become as important as the physical needs of the patient; these are openly addressed. Ask not “What’s the matter?” but instead “What matters to you?”

Timing the hospitalist’s return to see the patient and the anticipated date of transition of care is the last item in the rounding interaction. The date should be as accurate as possible to reduce patient anxiety and help the patient understand that the hospitalist really cares.

The hospitalist program has also strengthened the relationship between nurses and physicians. Nurses know the hospitalists’ practice patterns well, which allows them to help manage patient interactions and minimize patient anxiety and frustration. The physician-patient relationship is reinforced when nurse leaders include hospitalist satisfaction questions during daily rounding to identify concerns that can be clarified or resolved in real time.

The systematic VOC approach has enabled HCM to design, manage, and improve its key work process at multiple levels of the organization. These processes are reviewed and refined periodically to respond to the changing healthcare environment and stay focused on creating value for customers.

Chip Caldwell is chairman of Caldwell Butler, a firm specializing in coaching organizations to achieve world class performance in margin improvement, patient experience, physician/clinical enterprise, and capacity optimization. Jayne Pope, MBA, RN, is CEO of Hill Country Memorial Hospital in Fredericksburg, Texas. James Partin, MD, is CMO at Hill Country Memorial.

Understanding and improving the patient care experience has become a vital component of delivering high quality care. According to a new survey of American Society for Quality (ASQ) healthcare quality experts, more than 80% of respondents said improving communications between caregivers and patients and easing access to treatment across the entire continuum of care should be top priorities for improving patient experience. For Hill Country Memorial (HCM) in Fredericksburg, Texas, winner of the Malcolm Baldrige National Quality Award, accomplishing this kind of top-level patient experience performance involved engaging physicians—particularly hospitalists—using voice of the customer (VOC) input.

HCM did not achieve overnight success, however; instead, the facility achieved year-over-year improvement in finance and growth, patient experience, quality of care, and workforce environment and engagement (see Figure 1).

HCM developed a systematic VOC input-to-action process in which listening and learning methods during annual planning led them to institute a hospitalist program. Results included:

• Improved access to primary care, achieved by increasing the physicians’ hours of availability in their clinics, and improved work-life balance, enhancing engagement and alignment of the medical staff and HCM;
• Reductions in delays in admissions, discharges, and length of stay; and
• Real-time review and management of clinical data, not just during the daily rounding as had been done previously.

One of the major hurdles in the way of achieving patient satisfaction, according to the ASQ patient experience survey, is care that is fragmented and uncoordinated because of communication issues. HCM has overcome those hurdles using strategies such as a daily afternoon huddle in which hospitalists meet with a multidisciplinary team so that everyone understands patient action plans and current concerns. The process of discharge planning begins in these huddles so that more complex issues are initiated on day one of the hospital stay.

A new rounding communication process, called GIFT for greet, inform, find out, and time, has dramatically improved patient satisfaction and engagement. GIFT enables hospitalists to greet a patient with a personal introduction and an explanation of their position and responsibilities. Hospitalists always sit while engaging the patient, and they make it a point to acknowledge not only the patient but everyone present in the room. Personalized “baseball cards” featuring the hospitalist’s background, including personal interests and hobbies, are handed out to patients or family members. Hospitalists take time to inform the patient and appropriate family members and caregivers of all diagnostic test results and the clinical response of treatment to date. Treatment plans and further diagnostic tests or procedures are discussed. A report of all consultants who have joined or will be joining in the care, along with their roles in the treatment planned, is fully vetted.

One key to a successful patient experience is discovering the concerns of the patient, family members, friends, and caregivers. Emotional issues become as important as the physical needs of the patient; these are openly addressed. Ask not “What’s the matter?” but instead “What matters to you?”

Timing the hospitalist’s return to see the patient and the anticipated date of transition of care is the last item in the rounding interaction. The date should be as accurate as possible to reduce patient anxiety and help the patient understand that the hospitalist really cares.

The hospitalist program has also strengthened the relationship between nurses and physicians. Nurses know the hospitalists’ practice patterns well, which allows them to help manage patient interactions and minimize patient anxiety and frustration. The physician-patient relationship is reinforced when nurse leaders include hospitalist satisfaction questions during daily rounding to identify concerns that can be clarified or resolved in real time.

The systematic VOC approach has enabled HCM to design, manage, and improve its key work process at multiple levels of the organization. These processes are reviewed and refined periodically to respond to the changing healthcare environment and stay focused on creating value for customers.

Chip Caldwell is chairman of Caldwell Butler, a firm specializing in coaching organizations to achieve world class performance in margin improvement, patient experience, physician/clinical enterprise, and capacity optimization. Jayne Pope, MBA, RN, is CEO of Hill Country Memorial Hospital in Fredericksburg, Texas. James Partin, MD, is CMO at Hill Country Memorial.

Clinical question: Is post-procedural bridging therapy necessary for secondary prevention of VTE?

Background: Bridging therapy has been studied to stratify peri-procedural risk for patients with atrial fibrillation and mechanical heart valves. Data examining the necessity of post-procedural bridging for secondary prevention of VTE are lacking.

Study design: Retrospective, cohort study.

Setting: Single-state, integrated, healthcare delivery system.

Synopsis: A retrospective analysis of patients treated with warfarin for VTE prior to undergoing an invasive procedure was conducted from January 2006 through March 2012 to evaluate the occurrence of post-procedural bleeding secondary to bridging therapy, as well as the occurrence of VTE if bridging therapy was withheld.

Nearly 19,000 procedures were evaluated, of which 1,812 were included in the study. Of note, 11,710 procedures were excluded because the indication for anticoagulation was not VTE. The primary outcome was post-procedure bleeding events at 30 days, while secondary outcomes included severe bleeding events, recurrent VTE, and 30-day mortality. Patient risk of recurrent VTE was stratified into low-, medium-, and high-risk categories based on AT9 current guidelines.

Clinically relevant bleeding events occurred in 2.7% (15/555) of bridged patients and in 0.2% (2/1257) of non-bridged patients (hazard ratio of 17.2). With respect to VTE recurrence, there were three events in the non-bridged group and zero in the bridged group, which was not statistically significant (P=0.56). No VTE events were seen in the high-risk group, and there was no mortality at 30 days across any group.

Bottom line: Peri-procedural bridging therapy for VTE is associated with higher risk of bleeding, but there is not a significant risk of recurrent VTE if bridging therapy is withheld.

Citation: Clark NP, Witt DM, Davies LE, et al. Bleeding, recurrent venous thromboembolism, and mortality risks during warfarin interruption for invasive procedures. JAMA Intern Med. 2015;175(7):1163-1168. doi:10.1001/jamainternmed.2015.1843.

Clinical question: Is post-procedural bridging therapy necessary for secondary prevention of VTE?

Background: Bridging therapy has been studied to stratify peri-procedural risk for patients with atrial fibrillation and mechanical heart valves. Data examining the necessity of post-procedural bridging for secondary prevention of VTE are lacking.

Study design: Retrospective, cohort study.

Setting: Single-state, integrated, healthcare delivery system.

Synopsis: A retrospective analysis of patients treated with warfarin for VTE prior to undergoing an invasive procedure was conducted from January 2006 through March 2012 to evaluate the occurrence of post-procedural bleeding secondary to bridging therapy, as well as the occurrence of VTE if bridging therapy was withheld.

Nearly 19,000 procedures were evaluated, of which 1,812 were included in the study. Of note, 11,710 procedures were excluded because the indication for anticoagulation was not VTE. The primary outcome was post-procedure bleeding events at 30 days, while secondary outcomes included severe bleeding events, recurrent VTE, and 30-day mortality. Patient risk of recurrent VTE was stratified into low-, medium-, and high-risk categories based on AT9 current guidelines.

Clinically relevant bleeding events occurred in 2.7% (15/555) of bridged patients and in 0.2% (2/1257) of non-bridged patients (hazard ratio of 17.2). With respect to VTE recurrence, there were three events in the non-bridged group and zero in the bridged group, which was not statistically significant (P=0.56). No VTE events were seen in the high-risk group, and there was no mortality at 30 days across any group.

Bottom line: Peri-procedural bridging therapy for VTE is associated with higher risk of bleeding, but there is not a significant risk of recurrent VTE if bridging therapy is withheld.

Citation: Clark NP, Witt DM, Davies LE, et al. Bleeding, recurrent venous thromboembolism, and mortality risks during warfarin interruption for invasive procedures. JAMA Intern Med. 2015;175(7):1163-1168. doi:10.1001/jamainternmed.2015.1843.

Clinical question: Is post-procedural bridging therapy necessary for secondary prevention of VTE?

Background: Bridging therapy has been studied to stratify peri-procedural risk for patients with atrial fibrillation and mechanical heart valves. Data examining the necessity of post-procedural bridging for secondary prevention of VTE are lacking.

Study design: Retrospective, cohort study.

Setting: Single-state, integrated, healthcare delivery system.

Synopsis: A retrospective analysis of patients treated with warfarin for VTE prior to undergoing an invasive procedure was conducted from January 2006 through March 2012 to evaluate the occurrence of post-procedural bleeding secondary to bridging therapy, as well as the occurrence of VTE if bridging therapy was withheld.

Nearly 19,000 procedures were evaluated, of which 1,812 were included in the study. Of note, 11,710 procedures were excluded because the indication for anticoagulation was not VTE. The primary outcome was post-procedure bleeding events at 30 days, while secondary outcomes included severe bleeding events, recurrent VTE, and 30-day mortality. Patient risk of recurrent VTE was stratified into low-, medium-, and high-risk categories based on AT9 current guidelines.

Clinically relevant bleeding events occurred in 2.7% (15/555) of bridged patients and in 0.2% (2/1257) of non-bridged patients (hazard ratio of 17.2). With respect to VTE recurrence, there were three events in the non-bridged group and zero in the bridged group, which was not statistically significant (P=0.56). No VTE events were seen in the high-risk group, and there was no mortality at 30 days across any group.

Bottom line: Peri-procedural bridging therapy for VTE is associated with higher risk of bleeding, but there is not a significant risk of recurrent VTE if bridging therapy is withheld.

Citation: Clark NP, Witt DM, Davies LE, et al. Bleeding, recurrent venous thromboembolism, and mortality risks during warfarin interruption for invasive procedures. JAMA Intern Med. 2015;175(7):1163-1168. doi:10.1001/jamainternmed.2015.1843.

In this month's issue, our special report on the patient experience includes Dr. Jairy Hunter talking about things that impact the patient experience on the ward; Dr. Nasim Afsar discusses on how her love of science was sparked; and we feature the latest in HM clinical literature.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/09/September-2015-Hospitalist-Highlights.mp3"][/audio]

In this month's issue, our special report on the patient experience includes Dr. Jairy Hunter talking about things that impact the patient experience on the ward; Dr. Nasim Afsar discusses on how her love of science was sparked; and we feature the latest in HM clinical literature.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/09/September-2015-Hospitalist-Highlights.mp3"][/audio]

In this month's issue, our special report on the patient experience includes Dr. Jairy Hunter talking about things that impact the patient experience on the ward; Dr. Nasim Afsar discusses on how her love of science was sparked; and we feature the latest in HM clinical literature.

[audio mp3="http://www.the-hospitalist.org/wp-content/uploads/2015/09/September-2015-Hospitalist-Highlights.mp3"][/audio]

Clinical question: Does a short, fixed duration of antibiotic therapy for complicated intraabdominal infections lead to equivalent outcomes and less antibiotic exposure than the traditional approach?

Background: Published guidelines recommend appropriate antimicrobial agents for intraabdominal infections, but the optimal duration of therapy remains unclear. Most practitioners continue to treat for 10-14 days and until all physiologic evidence of the systemic inflammatory response syndrome (SIRS) has resolved. More recently, small studies have suggested that a shorter course may lead to equivalent outcomes with decreased antibiotic exposure.

Study design: Open-label, multicenter, randomized control trial.

Setting: Twenty-three sites throughout the U.S. and Canada.

Synopsis: In the short-course group, 257 patients were randomized to receive antimicrobial therapy for four full days after their index source-control procedure; 260 patients in the control group received antimicrobial therapy until two days after resolution of the physiological abnormalities related to SIRS. The median duration of therapy was 4.0 days (interquartile range [IQR], 4.0-5.0) for the experimental group and 8.0 days (IQR 5.0-10.0) in the control group (95% CI, -4.7 to -3.3; P<0.001).

There was no significant difference in surgical site infection, recurrent intraabdominal infection, or death between the experimental and control groups (21.8% vs. 22.3%, 95% CI -7.0 to 8.0; P=0.92). In the experimental group, 47 patients did not adhere to the protocol, all of whom received a longer antimicrobial treatment course than specified in the protocol.

This trial excluded patients without adequate source control and included a small number of immunocompromised hosts. The rate of nonadherence to the protocol was high, at 18% of patients in the experimental group. The calculated sample size to assert equivalence between groups was not achieved, although the results are suggestive of equivalence.

Bottom line: A shorter course of antimicrobial therapy for complicated intraabdominal infections might lead to equivalent outcomes with less antibiotic exposure compared with current practice; however, it is challenging for providers to stop antimicrobial therapy while patients continue to show physiologic evidence of SIRS.

Citation: Sawyer RG, Claridge JA, Nathens AB, et al. Trial of short-course antimicrobial therapy for intraabdominal infection. NEJM. 2015;372(21):1996-2005.

Clinical question: Does a short, fixed duration of antibiotic therapy for complicated intraabdominal infections lead to equivalent outcomes and less antibiotic exposure than the traditional approach?

Background: Published guidelines recommend appropriate antimicrobial agents for intraabdominal infections, but the optimal duration of therapy remains unclear. Most practitioners continue to treat for 10-14 days and until all physiologic evidence of the systemic inflammatory response syndrome (SIRS) has resolved. More recently, small studies have suggested that a shorter course may lead to equivalent outcomes with decreased antibiotic exposure.

Study design: Open-label, multicenter, randomized control trial.

Setting: Twenty-three sites throughout the U.S. and Canada.

Synopsis: In the short-course group, 257 patients were randomized to receive antimicrobial therapy for four full days after their index source-control procedure; 260 patients in the control group received antimicrobial therapy until two days after resolution of the physiological abnormalities related to SIRS. The median duration of therapy was 4.0 days (interquartile range [IQR], 4.0-5.0) for the experimental group and 8.0 days (IQR 5.0-10.0) in the control group (95% CI, -4.7 to -3.3; P<0.001).

There was no significant difference in surgical site infection, recurrent intraabdominal infection, or death between the experimental and control groups (21.8% vs. 22.3%, 95% CI -7.0 to 8.0; P=0.92). In the experimental group, 47 patients did not adhere to the protocol, all of whom received a longer antimicrobial treatment course than specified in the protocol.

This trial excluded patients without adequate source control and included a small number of immunocompromised hosts. The rate of nonadherence to the protocol was high, at 18% of patients in the experimental group. The calculated sample size to assert equivalence between groups was not achieved, although the results are suggestive of equivalence.

Bottom line: A shorter course of antimicrobial therapy for complicated intraabdominal infections might lead to equivalent outcomes with less antibiotic exposure compared with current practice; however, it is challenging for providers to stop antimicrobial therapy while patients continue to show physiologic evidence of SIRS.

Citation: Sawyer RG, Claridge JA, Nathens AB, et al. Trial of short-course antimicrobial therapy for intraabdominal infection. NEJM. 2015;372(21):1996-2005.

Clinical question: Does a short, fixed duration of antibiotic therapy for complicated intraabdominal infections lead to equivalent outcomes and less antibiotic exposure than the traditional approach?

Background: Published guidelines recommend appropriate antimicrobial agents for intraabdominal infections, but the optimal duration of therapy remains unclear. Most practitioners continue to treat for 10-14 days and until all physiologic evidence of the systemic inflammatory response syndrome (SIRS) has resolved. More recently, small studies have suggested that a shorter course may lead to equivalent outcomes with decreased antibiotic exposure.

Study design: Open-label, multicenter, randomized control trial.

Setting: Twenty-three sites throughout the U.S. and Canada.

Synopsis: In the short-course group, 257 patients were randomized to receive antimicrobial therapy for four full days after their index source-control procedure; 260 patients in the control group received antimicrobial therapy until two days after resolution of the physiological abnormalities related to SIRS. The median duration of therapy was 4.0 days (interquartile range [IQR], 4.0-5.0) for the experimental group and 8.0 days (IQR 5.0-10.0) in the control group (95% CI, -4.7 to -3.3; P<0.001).

There was no significant difference in surgical site infection, recurrent intraabdominal infection, or death between the experimental and control groups (21.8% vs. 22.3%, 95% CI -7.0 to 8.0; P=0.92). In the experimental group, 47 patients did not adhere to the protocol, all of whom received a longer antimicrobial treatment course than specified in the protocol.

This trial excluded patients without adequate source control and included a small number of immunocompromised hosts. The rate of nonadherence to the protocol was high, at 18% of patients in the experimental group. The calculated sample size to assert equivalence between groups was not achieved, although the results are suggestive of equivalence.

Bottom line: A shorter course of antimicrobial therapy for complicated intraabdominal infections might lead to equivalent outcomes with less antibiotic exposure compared with current practice; however, it is challenging for providers to stop antimicrobial therapy while patients continue to show physiologic evidence of SIRS.

Citation: Sawyer RG, Claridge JA, Nathens AB, et al. Trial of short-course antimicrobial therapy for intraabdominal infection. NEJM. 2015;372(21):1996-2005.

At A Glance

Series: Hospital Medicine: Current Concepts

Title: Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine

Edited by: James C. Pile, Thomas E. Baudendistel, Brian Harte

Series Editors: Scott Flanders, Sanjay Saint

Pages: 208

Clinical Care Conundrums is written in 22 chapters, each discussing a clinical case presentation in a format similar to the series by the same name, published frequently in the Journal of Hospital Medicine.

An expert clinician’s approach to the “clinical conundrums” is disclosed using the presentation of an actual patient case in a prototypical “morning report” style. As in a patient care situation, sequential pieces of information are provided to the expert clinician, who is unfamiliar with the case. The focus of each case is the thought processes of both the clinical team caring for the patient and the commentator.

Each case provides great learning potential, not only in the unusual presentation of common diseases or more typical presentations of unusual diseases, but also in discussions of the possibilities in differential diagnoses. The range of information is wide. Readers are taken through discussions of conditions infrequently encountered but potentially fatal in the event of missed or delayed diagnosis, such as strongyloides hyperinfection, a condition that we are reminded is not always accompanied by eosinophilia. Some discussions of the more common conditions include:

• Evaluation of confusion;
• Etiologies of cirrhosis;
• Malignancies associated with hypercalcemia; and
• Work-up for new-onset seizures.

My interest remained high throughout the book, because I never knew what to expect. For example, a patient presenting with acute chest pain caused by esophageal perforation resulting in delayed diagnosis might follow the index case presentation of Whipple’s disease. We are also reminded that, despite the insistence of Gregory House, MD, (Dr. House is the titular character from the television series “House”) that “it’s never lupus,” it sometimes is actually lupus. A couple of interesting lupus cases are presented in a realistically perplexing manner, followed by beneficial discussion.

Analysis

The real value in this book lies in continued reminders of how and why clinicians make diagnostic errors. In fact, an early chapter in the book deals explicitly with improving diagnostic safety.

Robert Wachter, MD, MHM, reminds us in the introductory chapter that diagnostic errors comprise nearly one in five preventable adverse events. Until recently, diagnostic errors have been given relatively little attention, most likely because they are difficult to measure and harder to fix.

As hospital-based providers, the more awareness we have about the “anatomy and physiology” of both good and faulty decision making, the more likely we are to make better decisions. This book can be a crucial resource for any hospital-based care provider.

Dr. Lindsey is medical director of hospital-based physician services at Hospital Corporation of America (HCA).

At A Glance

Series: Hospital Medicine: Current Concepts

Title: Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine

Edited by: James C. Pile, Thomas E. Baudendistel, Brian Harte

Series Editors: Scott Flanders, Sanjay Saint

Pages: 208

Clinical Care Conundrums is written in 22 chapters, each discussing a clinical case presentation in a format similar to the series by the same name, published frequently in the Journal of Hospital Medicine.

An expert clinician’s approach to the “clinical conundrums” is disclosed using the presentation of an actual patient case in a prototypical “morning report” style. As in a patient care situation, sequential pieces of information are provided to the expert clinician, who is unfamiliar with the case. The focus of each case is the thought processes of both the clinical team caring for the patient and the commentator.

Each case provides great learning potential, not only in the unusual presentation of common diseases or more typical presentations of unusual diseases, but also in discussions of the possibilities in differential diagnoses. The range of information is wide. Readers are taken through discussions of conditions infrequently encountered but potentially fatal in the event of missed or delayed diagnosis, such as strongyloides hyperinfection, a condition that we are reminded is not always accompanied by eosinophilia. Some discussions of the more common conditions include:

• Evaluation of confusion;
• Etiologies of cirrhosis;
• Malignancies associated with hypercalcemia; and
• Work-up for new-onset seizures.

My interest remained high throughout the book, because I never knew what to expect. For example, a patient presenting with acute chest pain caused by esophageal perforation resulting in delayed diagnosis might follow the index case presentation of Whipple’s disease. We are also reminded that, despite the insistence of Gregory House, MD, (Dr. House is the titular character from the television series “House”) that “it’s never lupus,” it sometimes is actually lupus. A couple of interesting lupus cases are presented in a realistically perplexing manner, followed by beneficial discussion.

Analysis

The real value in this book lies in continued reminders of how and why clinicians make diagnostic errors. In fact, an early chapter in the book deals explicitly with improving diagnostic safety.

Robert Wachter, MD, MHM, reminds us in the introductory chapter that diagnostic errors comprise nearly one in five preventable adverse events. Until recently, diagnostic errors have been given relatively little attention, most likely because they are difficult to measure and harder to fix.

As hospital-based providers, the more awareness we have about the “anatomy and physiology” of both good and faulty decision making, the more likely we are to make better decisions. This book can be a crucial resource for any hospital-based care provider.

Dr. Lindsey is medical director of hospital-based physician services at Hospital Corporation of America (HCA).

At A Glance

Series: Hospital Medicine: Current Concepts

Title: Clinical Care Conundrums: Challenging Diagnoses in Hospital Medicine

Edited by: James C. Pile, Thomas E. Baudendistel, Brian Harte

Series Editors: Scott Flanders, Sanjay Saint

Pages: 208

Clinical Care Conundrums is written in 22 chapters, each discussing a clinical case presentation in a format similar to the series by the same name, published frequently in the Journal of Hospital Medicine.

An expert clinician’s approach to the “clinical conundrums” is disclosed using the presentation of an actual patient case in a prototypical “morning report” style. As in a patient care situation, sequential pieces of information are provided to the expert clinician, who is unfamiliar with the case. The focus of each case is the thought processes of both the clinical team caring for the patient and the commentator.

Each case provides great learning potential, not only in the unusual presentation of common diseases or more typical presentations of unusual diseases, but also in discussions of the possibilities in differential diagnoses. The range of information is wide. Readers are taken through discussions of conditions infrequently encountered but potentially fatal in the event of missed or delayed diagnosis, such as strongyloides hyperinfection, a condition that we are reminded is not always accompanied by eosinophilia. Some discussions of the more common conditions include:

• Evaluation of confusion;
• Etiologies of cirrhosis;
• Malignancies associated with hypercalcemia; and
• Work-up for new-onset seizures.

My interest remained high throughout the book, because I never knew what to expect. For example, a patient presenting with acute chest pain caused by esophageal perforation resulting in delayed diagnosis might follow the index case presentation of Whipple’s disease. We are also reminded that, despite the insistence of Gregory House, MD, (Dr. House is the titular character from the television series “House”) that “it’s never lupus,” it sometimes is actually lupus. A couple of interesting lupus cases are presented in a realistically perplexing manner, followed by beneficial discussion.

Analysis

The real value in this book lies in continued reminders of how and why clinicians make diagnostic errors. In fact, an early chapter in the book deals explicitly with improving diagnostic safety.

Robert Wachter, MD, MHM, reminds us in the introductory chapter that diagnostic errors comprise nearly one in five preventable adverse events. Until recently, diagnostic errors have been given relatively little attention, most likely because they are difficult to measure and harder to fix.

As hospital-based providers, the more awareness we have about the “anatomy and physiology” of both good and faulty decision making, the more likely we are to make better decisions. This book can be a crucial resource for any hospital-based care provider.

Dr. Lindsey is medical director of hospital-based physician services at Hospital Corporation of America (HCA).